Launch Excellence V Surviving And Thriving When Launching .
White paperLaunch Excellence VSurviving and thriving when launchingin an increasingly specialised worldLisa Murch, Senior Consultant, Thought Leadership, QuintilesIMSSarah Rickwood, Vice President, European Thought Leadership, QuintilesIMSBill McClellan, Center of Excellence Leader, Launch Excellence, USBU, QuintilesIMSDr Simone Seiter, VP, Center of Excellence Lead Brand and Commercial Strategy, QuintilesIMS
Table of contentsIntroduction3A decade of Launch Excellence insight:what does it tell us about the future of the pharmaceutical industry?7Biologics in non-traditional biologic disease areas8Launch Archetypes9The Launch Excellence V study: approach11Oncology leading the specialty ascendance but competition is tough13The six month window remains all-powerful16Planning for where the ball will be: anticipating the future launch environment17What is likely to remain the same: developed markets focus18What is likely to change slowly: specialty focus for New Chemical Entities18 What is likely to change rapidly: payer attitudes to launch and the need forinnovative funding approaches18 What is likely to change rapidly: the impact of digital technologies, andmultichannel, on launch19 What could change fast but is highly uncertain: regulatory change in theUS and Europe20Exceptional patient insight Cost effective and highly responsive commercial model with orchestrated,multichannel customer engagement2222A mutually beneficial re-set of the payer partnership22Continued emphasis on alignment23References232 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com
IntroductionThe next decade will see greater concentration of competitionfor innovative Launches, with focus turning to more specialisttherapy areas, limited key launch countries, healthcarebudgets, doctor attention time, and even patients. Achievingtrue Launch Excellence will become even more challenging.To understand how to succeed in the future, companies mustfirst understand how today’s launch environment driverscame to be.Ten years ago, IMS Health (now QuintilesIMS) published a white paper entitled“Launch Excellence”. It defined objective criteria for excellence in launch forprescription medicines, and developed in-depth insight on medicines that achievedthem. We drew tough but surprising conclusions. For example, that the first six monthshas a disproportionate influence on later success for at least 80% of launches in anycountry. New Chemical Entity launch success is still, overwhelmingly, a developedmarkets game: 86% of the first five years’ sales of New Chemical Entities launchessince 2005 came from just seven countries: the US, Japan, Germany, France, UK,Spain and Italy.Our interviews with companies preparing for launch suggest the overwhelmingmajority, if asked, will classify themselves as “behind” on some or all aspects oftheir launch preparation. But some of these companies will go on to have excellentlaunches- others will not. Quality of preparation matters as well as quantity.3 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com86%86% of the first fiveyears’ sales of NewChemical Entitieslaunches since 2005came from just sevencountries
A decade of Launch Excellence insight: what does it tell usabout the future of the pharmaceutical industry?Launch Excellence is at the heart of many of the fundamental changes in thepharmaceutical industry’s landscape. Launches drive pharmaceutical industry change,so excellence in launch is the key to the pharmaceutical industry’s future.The decisive shift to specialty pharmaceutical product value growthThe first Launch Excellence white paper analysed launches back to 1995, an almostJurassic era when the big beasts of the pharmaceutical launch world were primarycare, mass market products: Lipitor, Plavix, Seretide, or Detrusitol. All of theseproducts were blockbusters in the billion dollars/year sense of the term but were verydifferent to today’s tranche of launches, whether excellent or not, as Figure 1 outlines.Figure 1: LE 1 drugs were without exception lower cost products forhigher prevalence conditionsLaunches by companyHigh costMultiple myelomaHepatitis CMultiple sclerosisIdiopathic pulmonary fibrosisHighprevalenceType 2 diabetesLowprevalenceAsthmaOsteoporosisErectile dysfunctionArthritisLaunch Excellence ILaunch Excellence VLow costDepressionSource: QuintilesIMS Thought Leadership Launch Excellence I and V;QuintilesIMS Pricing Insights; QuintilesIMS New Product FocusLE1 drugs were launched between 1995-2001 and LEV drugs were launched 2011-2015As Figure 2 shows, today’s Excellent launches are largely high cost products aimed atlow prevalence diseases treated by specialists. This reflects, largely, the Universe fromwhich the Excellent launches are sifted. This shift in scale has paved the way, at leastin part, for specialty companies with smaller-scale global commercial infrastructure toachieve outstanding launch success.4 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com
Figure 2: We are truly in the era of Specialty – very few primary care launches excel globallyProportion of Globally Excellent Launches by Primary care/specialty in LE I vs LE Vn 28n 3118%13%82%87%Launch Excellence I (1995-2003)Launch Excellence V (2011-2015)Primary careSpecialtyNotes: LEI drugs were launched between 1995-2001 and LEV drugs were launched 2011-2015Source: QuintilesIMS Thought Leadership Launch Excellence I and VWhile specialty is now30% of global prescriptionIn the late 1990s, the launch of the first biologic disease-modifying agents forrheumatoid arthritis, and targeted treatments for oncology sowed the seeds of thespecialty revolution. Specialty products, biologics or otherwise (all biologics apartfrom insulins are specialty products), share common characteristics: Treat complex and serious diseases Prescribed by specialists Usually expensive, with specialised distribution routes or methods of administrationSpecialty products are now leading drivers of value growth for the globalpharmaceutical market. While specialty is now 30% of global prescription medicinessales value, it approaches half of all medicines spending in the key developed marketsof the US, Japan and EU 5. For these key regions, specialty provides the vast majorityof current and future value growth.This shift to specialty value brings a host of profound changes. It has narrowedthe focus of launch success to a small number of developed, wealthy countries, forexample. As Figure 3 shows, total of 79% of all specialty value and 81% of growth inthe global pharmaceutical market comes from just seven countries: the US, Japan,Germany, France, Italy, Spain and the UK. These are also the markets which accountfor 86% of all first five year innovative launch sales.5 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.commedicines sales value,it approaches half of allmedicines spending in thekey developed markets.
Figure 3: 7 developed countries, including EU5, are 79% of all specialty sales and 81% of all specialty growthSpecialty: Region Market Share 2016Region Contribution to Global Growth12%15%Absolute growthcontribution in LCUS 13%8%7%79% of allspecialtysales from7 countries53%19%8%6%30%17%58%44%2011-2016 MarketUSPharmerging81% of allspecialtygrowth from7 countries2%9%Japan2011-2016 SpecialtyEU5ROWSource: QuintilesIMS MIDAS Q4 2016In Launch Excellence V, as Figure 4 shows, many more specialty than primary carelaunches are globally excellent; primary care – with the notable exception of diabetes– now has a patchier launch track record. Primary care sales value has grown in theUS and Japan but stalled in Europe, and partly by the international nature of thespecialty environment from an influencer/prescriber perspective.Figure 4: Breakdown of specialty and traditional launches by global excellence achievementNotexcellent24%Excellent in one ormore country.in two or morecountries.in three ormore CELLENCESource: QuintilesIMS Thought Leadership Launch Excellence model6 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com
Huge NCE launch focus on developed marketsThe key emerging markets, which QuintilesIMS terms pharmerging markets, havenever been strong contributors to the early sales of New Chemical Entity launches.Of 120 NCE launches which entered the world market between 2005 and 2015, only2.1% of aggregate sales five years post launch came from the BRICTM markets- that is,Brazil, Russia, India, China, Turkey and Mexico.The low contribution of the BRICTM to NCE global success is not new. It is afundamental difference between pharmerging and developed markets and is unlikelyto change in the near future. In fact, weakening of emerging economies and theirlack of widely accessible high-quality healthcare to support sophisticated, expensivespecialty launches, will only exacerbate this disparity.Decreasing target patient populationsMore than 80% of the Excellent launches of Launch Excellence I were primary careproducts. They were oral contraceptives, or treated dyslipidaemia, hypertension,depression, asthma, osteoporosis, COPD, osteoarthritis and overactive bladder conditions with global prevalence in the hundreds of millions, or billions. As Excellentlaunches like Lipitor, Plavix, or Diovan became blockbusters and then genericised,they made low cost, effective treatments available for the first time. This satisfiedunmet need and substantially reduced the market opportunity for similar laterentrants. There was immediate impact: Novartis’s Diovan follow up, Rasilez/Tekturna,failed to match Diovan’s success and now sells less than 200m worldwide, eventhough patents do not start to expire until 2020.80%More than 80% of theExcellent launches ofLaunch Excellence I wereprimary care products.The drastic reduction in high unmet need in primary care is one of the reasons whymost of the subsequent Excellent launches are in specialty areas, where treatmentwas often unsatisfactory, old, or non-existent, and unmet need was high. The mostrecent tranche of Excellent launches have very different target populations from thoseof LEI. Even relatively common and high profile cancers, such as Lung or Prostate,have an estimated annual incidence and prevalence in the low millions globally 1 – andthe specific cancer stages and/or subtypes that new launches target are smaller still.The very few Excellent launches in LEV for high prevalence diseases, in the order ofhundreds of millions, are in Hepatitis C and Type II diabetes (these are also the drugswith the best uptake trajectories in Pharmerging markets). In fact, diabetes is theonly therapy area to feature Excellent launches in both the first and the latest LaunchExcellence studies.What happened to the primary care market is now happening in specialty. Thematuration of many specialty therapy areas, for example, autoimmune biologics, hasstarted, and will accelerate over the next decade. This means the variety of situationswhich new specialty Launches will encounter will increase, with many more havingless differentiation and launching into areas with lower unmet need. Some companieswill launch into entirely specialty new therapy areas with no existing treatments, andthose new areas will increasingly be for rare or ultra-rare diseases. However, for manycompanies their challenge will be to make a success of a specialty launch into anexisting and maturing therapy area with decreasing unmet need.7 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.comFor many companies theirchallenge will be to makea success of a specialtylaunch into an existingand maturing therapyarea with decreasingunmet need.
A growing minority of new launches are now for rare or ultra-rare diseases. Taken asa whole, the unmet need in rare diseases (defined in the US as fewer than 200,000patients per condition) is substantial. An estimated 300 million individuals globallysuffer from such a disease, half of those affected are children, diagnosis times arelengthy, and only 5% of such conditions are currently treatable. Yet each condition hasat most a few million sufferers, and the very rarest may have only tens of patients. Rarediseases are often genetic in origin, with distributions within a few countries – 10% ofthe global cystic fibrosis (CF) population, for example, lives in the UK. Locating raredisease patients is becoming easier, as sequencing costs drop and patient networksimprove, but for rare disease launches, there is no wide-scale global opportunity.Higher launch product cost per patientLaunch Excellence I primary care products had list prices in the order of a fewhundreds to a few thousands of dollars a year in the US and other developed markets.A statin such as Lipitor, for example, was priced at a dollar a day (generic atorvastatinis cheaper still). This made sense for what were often preventative / symptomatictreatments for high prevalence and chronic conditions.Locating rare diseasepatients is becomingeasier, as sequencing costsdrop and patient networksimprove, but for raredisease launches, thereis no wide-scale globalopportunity.Costs for Launch Excellence V outstanding launches, meanwhile, typically rangefrom 10k- 100k plus per year. For many of these treatments the value proposition isquite different to that of earlier excellent launches. Sovaldi and Harvoni, for example,offer rapid and highly effective cures for a disease, Hepatitis C, with serious and lifethreatening potential consequences. In the case of excellent oncological launches,there have been some significant improvements in outcomes for previously intractablecancers.This price differential correlates only with limited increased returns for companies, whenadjusted for inflation. As Figure 5 shows, the average sales post-launch for Excellentdrugs launched in 1995-2003 are not substantially lower than those launched 2011-2015.Figure 5: Returns for top drugs in LEV are higher – but not dramatically – excluding the Hepatitis C drugs.Cumulative sales 24 months after launch, adjusted to US Consumer Price Index (2000)Cumulative sales (LC US Mn)1,200Adjusted to overall CPI600012 months18 monthsTime Since LaunchLE 1 averageLE V averageSources: European Thought Leadership Launch Excellence I and V model; Consumer Price Index, US Bureau of Labor Statistics8 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com24 months
The implication of these macro launch trendsTaken as a whole, the implications of these trends for launches is a greater focus interms of opportunity but also risk: T he US, Japan, Germany, France, Italy, Spain and the UK, account for 86% of all NCE launch sales, andfor specialty launches the share is higher still. Pharmerging markets have had historically low levels ofcontribution to NCE global sales, and a combination of pharmerging market slowdown and the specialistand expensive nature of many new launches will aggravate this. A narrower country focus can haveadvantages, but also concentrates risk. If a product launches poorly in the US, or worse, the USbecomes a less attractive launch market, launches suffer globally, and there are no country alternativesto make up the deficit. Increased pressure on pricing and a volatile political situation in the US raisesthe risk for future launches; companies need to insulate against this by optimizing ex-US sales. T he annual patient populations that launches (Excellent or otherwise) target, have dropped from a typical100s of millions of patients globally to a few million. Genotyping and other population segmentationmethodologies are likely to perpetuate this trend. Small patient populations are cared for by smallnumbers of specialist healthcare professionals. The value of individuals grows exponentially, andpharmaceutical companies must not only understand them better but, in an ethical and patient-leadfashion, develop effective relationships with them. Patient-centricity is not just a gimmick or a slogan,but an absolute necessity. Likewise, the value of each pharmaceutical company interaction with thehealthcare professionals treating and supporting these patients has also risen sharply – at a time whengetting face to face interaction with doctors has become even more challenging. A mature multichannelmodel which allows consistent and effective communication across a broad spectrum of channels isabsolutely essential. A s patient numbers have declined, the annual cost per patient for many new launches has risen. Inmany cases this accompanies a breakthrough in the treatment of a serious disease. Stress points in thedialogue with payers are growing, however, and launches, excellent and non-excellent, drive this.Drug pricing is an easy target for policymakers to cut healthcare spending. New approaches to breakthe deadlock between payers and companies on price and market access are an essential part ofLaunch ExcellenceThese factors raise two broader questions: In an era when pressure on costs has never been fiercer, and issues such as the growing funding crisisin social care intensify scrutiny of healthcare spend, are the trends in innovation and launch sustainable?The age of easy wins in both primary care and specialty has come to an end. Companies may needto revise their expectations of launch from high, fast success to steady incremental increases withinboundaries negotiated with payers. Are today’s launches truly addressing the largest unmet needs in terms of both severity of disease andnumber of affected patients? Large unmet need undoubtedly exist in areas such as CNS and pain, whichhave seen several cycles of innovation, now largely or entirely genericised. Can companies address thesewith new types of Excellent launch that demonstrate credible value for the sub-populations with remainingunmet need?9 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com
Launch ArchetypesThe first wave of primary care excellent launches have genericised and pioneerspecialty launches have matured. This means that there are multiple situations a newlaunch could now enter. Using its database of hundreds of launches, QuintilesIMS hasdefined four Launch Archetypes – situations encountered repeatedly across therapyareas and countries. The common, defining characteristics are based on the level ofdifferentiation of the product and the unmet need within its disease area:1.“Science sells” – high unmet need and high product differentiation2. “It’s about shaping the market/product” – low unmet need and high product differentiation3. “Emphasise the difference”- high unmet need and low product differentiation4. “Who benefits” – low unmet need and low product differentiationRegardless of whether products are launching into mass market, primary care orhighly specialist, narrow patient population therapy areas, we found multiple launcheswhich fitted into each category, with profoundly different outcomes dependent uponarchetype – the logical reaction by the market to each Launch situation. “Sciencesells” launches averaged the highest sales in their first year whereas the “Whobenefits” launches of low differentiation into a low unmet need market averagedsignificantly less in their first year. Archetypes 2 (“Shaping the market/product”) and 3(“Emphasise the difference”) fall between these two extremes but it is differentiationthat is the more decisive driver.The market rewards unmet need and product differentiation, but where unmet need islow, a well differentiated pr
TABLE of ConTEnTS 2 Launch Excellence V: Surviving and thriving when launching in an increasingly specialised world www.quintilesims.com. Introduction The next decade will see greater concentration of competition for innovative Launches, with focus turning to more specialist
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